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Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture

Primary Purpose

Dupuytren Contracture, Dupuytren's Disease, Contracture

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Percutaneous needle fasciotomy
Corticosteroid injection
Saline injection
Sponsored by
Regionshospitalet Silkeborg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dupuytren Contracture focused on measuring Percutaneous needle fasciotomy, Corticosteroid, Randomized controlled trial

Eligibility Criteria

45 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Sufficient correction of metacarpophalangeal (MCP) joint during the PNF treatment, defined as <20° passive extension deficit (PED), is a prerequisite for inclusion.

Inclusion Criteria:

  • Dupuytren contracture (DC) of ≥ 20° PED in MCP joint measured with a goniometer
  • DC of either II-V finger
  • Well-defined/palpable cord

Exclusion Criteria:

  • Legally incapacitated
  • Previous study inclusion with another finger ray
  • Isolated proximal interphalangeal (PIP) or distal interphalangeal (DIP) joint contracture, defined as MCP joint contracture < 20° PED regardless of the deficit in the PIP or DIP joint
  • Previous hand surgery of the affected finger for any reason
  • Known allergy to the study medication
  • Anticoagulant therapy (Acetylsalicylic acid is NOT an exclusion criterion)
  • Pregnant or lactation
  • Insulin dependent diabetes mellitus
  • Ongoing systemic infection or local infection at the site of the procedure
  • Rheumatoid arthritis
  • Amyloidosis or mucopolysaccharidosis
  • Unable to communicate, cooperate or participate in follow-up

Sites / Locations

  • Silkeborg Regional HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Corticosteroid injection

Saline injection

Arm Description

Percutaneous needle fasciotomy with corticosteroid injection

Percutaneous needle fasciotomy with saline injection

Outcomes

Primary Outcome Measures

Recurrence rate
Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline

Secondary Outcome Measures

Full Information

First Posted
June 27, 2022
Last Updated
May 15, 2023
Sponsor
Regionshospitalet Silkeborg
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1. Study Identification

Unique Protocol Identification Number
NCT05440240
Brief Title
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture
Official Title
Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
March 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regionshospitalet Silkeborg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren Contracture, Dupuytren's Disease, Contracture, Joint Diseases, Musculoskeletal Diseases, Fibroma, Neoplasm, Fibrous Tissue, Neoplasms, Connective Tissue, Neoplasms, Connective and Soft Tissue, Neoplasms by Histologic Type, Neoplasms, Connective Tissue Diseases
Keywords
Percutaneous needle fasciotomy, Corticosteroid, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Corticosteroid injection
Arm Type
Active Comparator
Arm Description
Percutaneous needle fasciotomy with corticosteroid injection
Arm Title
Saline injection
Arm Type
Placebo Comparator
Arm Description
Percutaneous needle fasciotomy with saline injection
Intervention Type
Procedure
Intervention Name(s)
Percutaneous needle fasciotomy
Intervention Description
Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre
Intervention Type
Drug
Intervention Name(s)
Corticosteroid injection
Intervention Description
Depo-Medrol
Intervention Type
Other
Intervention Name(s)
Saline injection
Intervention Description
Isotonic saline
Primary Outcome Measure Information:
Title
Recurrence rate
Description
Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Sufficient correction of metacarpophalangeal (MCP) joint during the PNF treatment, defined as <20° passive extension deficit (PED), is a prerequisite for inclusion. Inclusion Criteria: Dupuytren contracture (DC) of ≥ 20° PED in MCP joint measured with a goniometer DC of either II-V finger Well-defined/palpable cord Exclusion Criteria: Legally incapacitated Previous study inclusion with another finger ray Isolated proximal interphalangeal (PIP) or distal interphalangeal (DIP) joint contracture, defined as MCP joint contracture < 20° PED regardless of the deficit in the PIP or DIP joint Previous hand surgery of the affected finger for any reason Known allergy to the study medication Anticoagulant therapy (Acetylsalicylic acid is NOT an exclusion criterion) Pregnant or lactation Insulin dependent diabetes mellitus Ongoing systemic infection or local infection at the site of the procedure Rheumatoid arthritis Amyloidosis or mucopolysaccharidosis Unable to communicate, cooperate or participate in follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura H Matthiesen, MS, PhD-student
Phone
004561281917
Email
lather@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jeppe Lange, MD, PhD
Email
jepplang@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeppe Lange, MD, PhD
Organizational Affiliation
Horsens Regional Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Silkeborg Regional Hospital
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura H Matthiesen, PhD Student
Phone
004561281917
Email
lather@rm.dk
First Name & Middle Initial & Last Name & Degree
Jeppe Lange, MD, PhD
Email
jepplang@rm.dk

12. IPD Sharing Statement

Plan to Share IPD
No

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Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture

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